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The NeuroMate Stereotactic System is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments.
The NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic System are intended for the sterectactic spatial positioning and onlentation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).
NeuroMate assists the surgeon in its operating tasks by providing a stable, accurate, and reproducible mechanical guidance for surgical instruments, while not directly entering in contact with the patient's head. The instrument holder's sterectactic soatial positioning and orientation are determined by the neurosurgeon using an "external" (i.e., not provided by IMMI Inc.) imaging software for stereotactic planning and specific to the intended clinical application.
The NeuroMate Stereotactic System acts like a motorized stereotactic frame driven by the external imaging software supported by a PC or a computer workstation providing visualization of anatomical structures and brain targets specific for the intended application (e.g., 3-D image databases from CT, MR, DSA, PET, SPECT),
Following a carefully prepared stereotactic treatment plan, at the neurosumeon request. the NeuroMate Stereotactic System slowly moves and subsequently nointains an instrument holder proximal to the patient's head: NeuroMate automatically and accurately insure the correct stereotactic angular and spatial positioning of surgical instruments, thereby reducing potential human errors. During most of the duration of a neurosurgical procedure, NeuroMate is motionless and the instrument holder rigidly holds the surgical instrument chosen by the neurosurgeon prior to initiating stereotactic surgery. Only when changing spatial position and/or orientation does NeuroMate actually move. Finally, NeuroMate must be used in conjunction with a stereotactic head ring.
The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:
- electronic and PC circuit boards powered by switching power supplies: .
- an electromechanical 5-axis multiliointed arm displaced by 24V DC motors: .
- a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.
The NeuroMate Stereotactic System's controller has been specifically developed for surgical applications. It includes several functions at the mechanical and software levels, which, in case of dysfunction, quarantee the patient safety and the medical staff safety.
NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:
- an axis controller for each joint: .
- a main controller module coordinating NeuroMate's motion; it performs the . necessary transformations between the Cartesian space and joint space;
- a field bus linking the main controller to the axis controllers; .
- a supervisor module performing all functions related to user interface, and . generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.
The provided document describes the NeuroMate Stereotactic System and its performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather "performance specifications." These are presented as the results of different testing sequences. Based on the "Performance Data" section and Table A (Continued), the following can be constructed:
| Performance Metric | Acceptance Criteria (Implicit from Predicate Devices / Performance Specifications) | Reported Device Performance (NeuroMate Stereotactic System) |
|---|---|---|
| Location Accuracy | < 1.5 mm (Based on BRW) or < 0.7 mm (Based on COMPASS) | < 0.75 mm (Measured: 0.73 mm) |
| Angular Accuracy | < 0.5° (Based on BRW) | < 0.14° (Measured: 0.14°) |
| Repeatability | (Not explicitly stated for predicate devices, but for NeuroMate) | < 0.15 mm (Measured: 0.136 mm) |
Note: The acceptance criteria are inferred from the performance data of the predicate devices (BRW and COMPASS) and the "performance specifications" mentioned in the text against which NeuroMate's measured performance is compared. The document states, "The results of these measurements are well within the performance specifications of the device."
2. Sample Size Used for the Test Set and Data Provenance
The document describes pre-clinical testing ("Overall performances... were assessed as a result of different testing sequences") and clinical testing.
- Pre-clinical Test Set: No specific sample size (e.g., number of measurements) is explicitly stated for the pre-clinical tests that measured accuracy and repeatability. It's implied these were laboratory measurements.
- Clinical Test Set:
- Sample Size: A cohort of 45 patients (16 females; 29 males, mean age 42 years, range 8-75).
- Data Provenance: Prospective, conducted between September 1995 and April 1996, at the Neurosurgery Department of Grenoble University Hospital in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For the clinical test set: The ground truth for the device's performance in patient procedures was established by the neurosurgeons at Grenoble University Hospital. The document states, "The treatment strategy... are entirely left under the neurosurgeon's control," and "NeuroMate performed as intended and successfully positioned the instrument holder at the required stereotactic spatial and angular position," and "following readjustment judged clinically necessary by X-ray control in-situ." It also mentions " deviations between requested positioning and clinically optimal positioning were < 2mm in 65% of the cases without simulation, and increased to 97% with treatment simulation." This indicates that neurosurgeons made the clinical judgments and assessed the "clinically optimal positioning."
- Number of Experts: Not explicitly stated, but it would have been the neurosurgical staff involved in the 45 cases.
- Qualifications of Experts: They are referred to as "neurosurgeons" at a university hospital, implying specialized medical training and expertise in neurosurgery. No specific years of experience are provided.
4. Adjudication Method for the Test Set
- For the clinical test set: The document implies a form of clinical judgment/adjudication by the operating neurosurgeon(s). The decision for "readjustment judged clinically necessary by X-ray control in-situ" implies the surgeon(s) assessed the initial positioning and decided if it met clinical requirements, potentially using X-ray feedback for confirmation. There is no mention of an independent adjudication panel or a specific numeric rule (like 2+1 or 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no MRMC comparative effectiveness study described in the document. The study described is a clinical trial assessing the performance of the NeuroMate Stereotactic System itself, not a comparison of human readers with vs. without AI assistance. The NeuroMate assists the surgeon in positioning, but the decision-making remains with the surgeon. No effect size for human reader improvement with AI assistance is provided.
6. Standalone (Algorithm Only) Performance
The document describes the performance of the device (NeuroMate Stereotactic System) as a standalone system in terms of its mechanical accuracy and repeatability (0.73 mm positioning accuracy, 0.14° angular accuracy, 0.136 mm repeatability). The device "acts like a motorized stereotactic frame driven by the external imaging software." While external software provides the plan, the NeuroMate's physical movement and positioning capabilities (the electromechanical arm) are assessed independently from direct human interaction for its core mechanical performance metrics. However, its clinical effectiveness is still within the human-in-the-loop surgical context.
7. Type of Ground Truth Used
- For pre-clinical performance (accuracy, repeatability): The ground truth was known locations in space or the ability to return to the same position, measured in a controlled laboratory setting (likely using precision measurement tools).
- For clinical performance: The ground truth was based on clinical assessment and judgment by neurosurgeons, often supported by X-ray control in-situ to determine "clinically optimal positioning" and whether "readjustment" was needed.
8. Sample Size for the Training Set
The document does not mention a training set in the context of machine learning or AI algorithm development. The NeuroMate system is described as a "computer controlled image-guided electromechanical multijointed arm" driven by "external imaging software." While such software might have been developed using training data, the document focuses on the device's mechanical and clinical performance, not the training of an internal AI component.
9. How Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is described, this information is not applicable based on the provided document. The NeuroMate itself is a robotic arm, not an AI diagnostic/prognostic algorithm that requires a training set in the typical sense.
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